Regeneron Pharmaceuticals Inc (REGN) and Sanofi (SNY) Win FDA Approval of DUPIXENT


Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi (NYSE:SNY) announced that the FDA approved DUPIXENT® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

“People with moderate-to severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” said Julie Block, President and Chief Executive Officer, National Eczema Association. “To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease.”

DUPIXENT is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. DUPIXENT comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. DUPIXENT can be used with or without topical corticosteroids. It should not be used in patients who are allergic to dupilumab or any of the ingredients in DUPIXENT.

AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe AD is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating. Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.

“DUPIXENT is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases. In atopic dermatitis, DUPIXENT was shown to help clear the skin and manage the intense itch caused by the disease,” said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron. “Today’s approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program.”

DUPIXENT was evaluated by the FDA with Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions. This followed the FDA’s 2014 Breakthrough Therapy designation for DUPIXENT for inadequately controlled moderate-to-severe AD. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs developed for serious or life-threatening conditions.  DUPIXENT represents the first time this designation was granted for a dermatological disease, other than in dermatologic cancers.

“We strive to transform scientific innovation into therapeutic solutions that make a meaningful difference to people’s lives,” said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. “The approval of DUPIXENT offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally.”

Shares of Regeneron are currently trading at $376.99, down $6.69 or -1.74% . REGN has a 1-year high of $452.96 and a 1-year low of $325.35. The stock’s 50-day moving average is $375.02 and its 200-day moving average is $378.53.

On the ratings front, Regeneron has been the subject of a number of recent research reports. In a report released today, Leerink analyst Geoff Porges reiterated a Buy rating on REGN, with a price target of $448, which represents a potential upside of 17% from where the stock is currently trading. Separately, on March 23, Oppenheimer’s Hartaj Singh reiterated a Hold rating on the stock.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Geoff Porges and Hartaj Singh have a yearly average loss of -1.3% and -2.7% respectively. Porges has a success rate of 38% and is ranked #3517 out of 4555 analysts, while Singh has a success rate of 57% and is ranked #3656.

Overall, 12 research analysts have assigned a Hold rating and 7 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $397.63 which is 3.7% above where the stock opened today.

Regeneron Pharmaceuticals, Inc. operates as a biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. The company involves in marketing medicines for eye diseases, colorectal cancer and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma and atopic dermatitis. 

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